The Ministry of Food and Drug Safety announced that there is no major problem with the safety and effectiveness of the flu (influenza) vaccine in which white particles were found.
The white particles have been found to originate from a protein that was the original component of the flu vaccine.
In order to relieve public anxiety, the Ministry of Food and Drug Safety plans to dispose of the entire flu vaccine recovered from the discovery of white particles according to procedures.
The Ministry of Food and Drug Safety announced today (27th) the results of the characterization, antigen content test, and animal test of the Korean vaccine recovered from the discovery of white particles.
First of all, to analyze the characteristics of white particles, the Ministry of Food and Drug Safety compared the flu vaccine in which white particles were found with the World Health Organization (WHO) flu vaccine standard and other companies' normal flu vaccines.
As a result of comparing and analyzing the size and distribution pattern of the protein, the product producing white particles did not show much difference from the control group.
The white particles found in flu vaccines have been identified as influenza proteins that make up the vaccine.
This is not different from what the Ministry of Food and Drug Safety had originally estimated.
Earlier, when the Ministry of Food and Drug Safety announced on the 9th of this month that it would recover 615,000 flu vaccines in which white particles were found, the particles have been estimated to be protein masses originating from the vaccine.
Antigen content tests for the effectiveness of vaccines in which white particles were produced were also found to meet the criteria.
It means there is no problem with the effectiveness of the vaccine.
The antigen content test is an internationally accepted test method that quantifies the antigen content in flu vaccines by comparing the level of antigen-antibody reactions with the WHO standard.
Animal testing concluded that there were no safety concerns.
The Ministry of Food and Drug Safety conducted an autopsy and histopathology after injecting the flu vaccine, which found white particles, into rabbits for three days.
As a result, there were no specific findings other than general reactions from vaccine administration, such as redness of the skin at the injection site.
The Ministry of Food and Drug Safety concluded that there were no problems with the safety and effectiveness of the flu vaccine containing white particles after the results of these tests and three expert discussions.
It was concluded that the influenza vaccine with white particles had no problems with safety and effectiveness, but the Ministry of Food and Drug Safety decided to discard the entire product in question, independent of the test results.
Yang Jin-young, deputy head of the Ministry of Food and Drug Safety, said, "There is actually no problem with safety or effectiveness, but in order to eliminate public anxiety about the flu vaccine, the company voluntarily retrieved it, and it is a principle to discard the recovered quantity if there is no specific matter."
Currently, the Ministry of Food and Drug Safety has received a report from the Korean vaccine that the product has been recovered and is being verified.
If the Ministry of Food and Drug Safety determines that the collection has ended, the product will undergo a disposal procedure.
The Food and Drug Administration is also investigating the cause of white particles in the flu vaccine.
The direct cause has not yet been identified, but it is said that it is still being pursued.
In particular, white particles were found only in the flu vaccine contained in a specific undiluted solution and a specific syringe, so we are investigating and analyzing this part with experts.
(Photo = Provided by the Ministry of Food and Drug Safety, Yonhap News)